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The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair and Meniscal Root Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 – 5.5 Anchors only).
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors are sterile, single-use, and non-pyrogenic.

The provided FDA 510(k) clearance letter and summary for the OSSIOfiber® Suture Anchor (K251309) primarily focus on non-clinical performance data to support substantial equivalence. It's important to note that this document does not describe a study involving human subjects or AI-assisted diagnosis/treatment. Instead, it details a mechanical device and its performance for surgical fixation.

Therefore, many of the requested elements pertaining to AI, human readers, ground truth establishment for clinical data, and training/test set samples for AI models are not applicable to this specific submission.

However, we can extract information regarding the acceptance criteria and the study (non-clinical) that proves the device meets the acceptance criteria as presented in the document.

Analysis of Acceptance Criteria and Device Performance (Non-Clinical)

The submission for the OSSIOfiber® Suture Anchor (K251309) is a Special 510(k) premarket notification to expand the existing indications for use to include "Meniscal Root Repair." The core of the justification for substantial equivalence relies on demonstrating that the device's performance for this new indication is comparable to its predicate devices, primarily through non-clinical (mechanical) testing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table with numerical acceptance criteria and corresponding reported device performance values in the format typically seen for clinical or AI studies. Instead, the "acceptance criteria" are implied by demonstrating equivalent or superior mechanical performance to the predicate devices for critical aspects relevant to a suture anchor (e.g., fixation strength, degradation characteristics).

The study that proves the device meets (or aligns with) these implied criteria is the non-clinical testing previously conducted and referenced.

Note: The document only provides meta-information about the testing (that it was done, and what kind), not the raw numerical results or specific acceptance thresholds. The "rationale" refers to the interpretative analysis of that data.

2. Sample Size and Data Provenance (for the mechanical test)

• Sample Size: The document states that the rationale for the new indication was "based on the comparative static pull-out and cyclic pull-out testing included within K213415." However, the exact sample sizes (e.g., number of anchors tested, number of cycles) for the static and cyclic pull-out tests are not specified in this 510(k) summary. This information would typically be found in the full test reports referenced in the initial K213415 predicate submission.
• Data Provenance: The testing is non-clinical (laboratory-based mechanical testing). It's not data from human subjects or collected from real-world patients. The origin of the data is from the device manufacturer's (Ossio Ltd.) internal testing, likely at a certified testing facility.
  • Country of Origin: Not explicitly stated for the testing, but Ossio Ltd. is based in Caesarea, Israel.
  • Retrospective or Prospective: This distinction doesn't fully apply to mechanical testing in the same way it does to clinical studies. The tests were performed prospectively according to established protocols to generate data for regulatory submission.

3. Number of Experts and their Qualifications (for mechanical testing)

This question is Not Applicable in the context of this mechanical device submission, as the "ground truth" is established through physical measurements and engineering principles, not expert human interpretation like in AI/imaging studies. The "experts" involved would be engineers and technical specialists conducting and analyzing the mechanical tests according to industry standards.

4. Adjudication Method (for mechanical testing)

This question is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in human expert interpretations (e.g., radiology reads). For mechanical testing, the "ground truth" is directly measured, and results are verified through standard quality control and robust test methodologies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a question relevant to AI-assisted diagnostic or imaging devices, not a mechanical surgical implant. No human readers or AI assistance in interpretation are involved in the use or evaluation of a suture anchor.

6. Standalone (Algorithm Only) Performance

Not Applicable. This would apply to AI algorithms. The OSSIOfiber® Suture Anchor is a physical medical device, not an algorithm.

7. Type of Ground Truth Used (for the mechanical testing)

• The "ground truth" for this device's performance is established through physical, quantifiable measurements from standardized mechanical tests.
  • Static Pull-out: The maximum force required to pull the anchor out of simulated bone material.
  • Cyclic Pull-out: The anchor's resistance to displacement or failure under repeated loading cycles.
  • Material Degradation: Chemical and physical analysis of the material over time (e.g., mass loss, molecular weight changes, mechanical property retention).
• It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set (for a mechanical device)

Not Applicable. This concept applies to machine learning models. For a mechanical device, there isn't a "training set" in the AI sense. Design and material selection are based on engineering principles and prior knowledge, not iterative training on data.

9. How the Ground Truth for the Training Set was Established (for a mechanical device)

Not Applicable. As there is no AI training set, this question is not relevant. The "truth" about the materials and design comes from established scientific and engineering principles, material characterization, and prior performance data of similar devices and materials. The non-clinical data demonstrates the performance of the final device, not establishes ground truth for a training set.

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The OSSIOfiber® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Specific indications are listed below:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcromioClavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure

• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

The OSSIOfiber® Suture Anchor 2.5-3.5 mm, consists of an anchor preloaded on an inserter. The anchor is made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors 2.5-3.5mm are supplied sterile, for single patient use only.

The OSSIOfiber® Suture Anchors 2.5-3.5mm are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided text is an FDA 510(k) clearance letter and its associated 510(k) Summary. It describes a medical device, the OSSIOfiber® Suture Anchor 2.5-3.5 mm, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics that would typically apply to AI/ML or diagnostic devices.

The document focuses on demonstrating substantial equivalence for a physical implantable device, which relies on comparing its technological characteristics (intended use, materials, design, principles of operation, manufacturing, sterilization) and performance (mechanical testing, biocompatibility) to already cleared devices. It does not involve a diagnostic or predictive algorithm, thus many of the criteria requested (e.g., test set sample size, expert ground truth, MRMC study, standalone performance) are not applicable.

Here's an analysis based on the information provided, highlighting the differences in context:

1. A table of acceptance criteria and the reported device performance:

Since this is a physical medical device clearance, the "acceptance criteria" are not reported as specific numerical benchmarks for diagnostic performance (like sensitivity or specificity). Instead, they relate to demonstrating comparable safety and effectiveness through a combination of:

• Technological Characteristics: The device must have substantially similar or identical intended use, principles of operation, material composition, design, manufacturing, and sterilization methods as predicate devices.
• Performance (Non-Clinical): Mechanical properties (strength, fixation) and biological response (biocompatibility) must be at least equivalent to the predicate device.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify a "test set sample size" in the context of diagnostic performance. For mechanical testing, the number of devices or constructs tested for static and cyclic pull-out is not explicitly stated. The "in-vitro degradation profile" was characterized, but the sample size for this is also not given.
• Data Provenance: The mechanical testing and degradation characterization were performed "in-vitro." Biocompatibility was established based on ISO 10993 data from previously cleared devices and rationales. This suggests laboratory-based testing and references to existing, accepted data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This question is not applicable. The device is a surgical implant, not a diagnostic tool requiring expert interpretation of images or data to establish a "ground truth" for a test set. The "ground truth" for a device like this would be established through established engineering and biological standards and clinical experience with predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable as there is no diagnostic or interpretive test set requiring adjudication in this context.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI assistance effect size is relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. This is a physical implantable device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this type of device, the "ground truth" is typically defined by:

• Established engineering standards: Performance metrics like pull-out strength, cyclic fatigue, and degradation rates are measured against accepted industry standards or the performance of legally marketed predicate devices, which are deemed safe and effective.
• Biocompatibility standards: Compliance with ISO 10993 series for biological evaluation of medical devices, which typically involves in-vitro and/or in-vivo testing, leading to a conclusion of acceptable biological risk.
• Clinical history of predicate devices: The "ground truth" for safety and effectiveness is largely based on the long-term clinical use and acceptance of the predicate technologies (similar design, materials, surgical indications).

8. The sample size for the training set:

This is not applicable. There is no concept of a "training set" for this type of physical medical device in the context of this 510(k) submission.

9. How the ground truth for the training set was established:

This is not applicable, as there is no training set.

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